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Recruiting Not applicable

Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

NCT06213168 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-08-19
Last updated
2026-04-13

Condition(s) studied

De Novo Hypoxemic Acute Respiratory Failure (hARF)

Investigational drug(s) / intervention(s)

HFNCCPAP and HFNC

HFNC: Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization

CPAP and HFNC: Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions

Study summary

De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed.

Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate.

The present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a Prospective, Randomized Controlled Trial

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adults (≥ 18 years old) 2. Admitted in the ICU for ≤ 24 hours 3. De novo hARF defined by the three following criteria: 1. Respiratory rate \> 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration 2. PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered. 3. Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan 4. Informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent Exclusion Criteria: 1. Refusal of study participation by the patient or the proxy 2. Anatomical factors precluding the use of a nasal cannula or CPAP 3. Long term oxygen 4. Home CPAP or NIV or CPAP or NIV initiated prior to ICU admission 5. Hypercapnia indicating NIV (PaCO2 \> 45 mmHg) 6. Isolated cardiogenic pulmonary oedema indicating NIV 7. Known pregnancy or breastfeeding 8. Absence of coverage by the French statutory health care insurance system (including AME) 9. Abdominal, thoracic or cardiac surgery within the last 6 days 10. Use of vasopressors (norepinephrine\>0.3 mcg/kg/min) 11. Glasgow coma scale \< 13 12. Urgent need for endotracheal intubation 13. Patients at an end-of-life stage receiving compational oxygenation 14. Exacerbation of a chronic respiratory disease 15. Legal protection (curatorship or tutorship) 16. Undrained pneumothorax

Primary outcome measure(s)

  • Mortality — 90 days
    Time to death within the 90 days after randomization

Trial sites (29)

FacilityCityRegionStatus
CHU Amiens-Picardie Amiens France Not Yet Recruiting
CHU Angers Angers France Not Yet Recruiting
Centre Hospitalier Victor Dupouy Argenteuil France Not Yet Recruiting
Hôpital Avicenne Bobigny France Not Yet Recruiting
Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat Bourg-en-Bresse France Recruiting
Hôpital Louis-Mourier Colombes France Not Yet Recruiting
Centre Hospitalier Sud Francilien Corbeil-Essonnes France Not Yet Recruiting
Hôpital Henri-Mondor Créteil France Recruiting
Centre Hospitalier de Dieppe - Site Pasteur Dieppe France Recruiting
Hôpital François Mitterrand Dijon France Recruiting
Hôpital André Mignot Le Chesnay France Recruiting
Hôpital Bicêtre Le Kremlin-Bicêtre France Not Yet Recruiting
Centre Hospitalier du Mans Le Mans France Recruiting
Hôpital Salengro Lille France Recruiting
Hôpital Édouard Herriot - Hospices Civils de Lyon Lyon France Recruiting
Hôpital de la Croix-Rousse - Hospices Civils de Lyon Lyon France Recruiting
Hôpital Saint-Joseph Saint-Luc Lyon France Not Yet Recruiting
Hôpital Lyon Sud - Hospices Civils de Lyon Lyon France Not Yet Recruiting
Hôpital Lapeyronie Montpellier France Recruiting
CHU de Nantes Nantes France Not Yet Recruiting
Hôpital Pasteur Nice France Active Not Recruiting
Hôpital de l'Archet Nice France Recruiting
Hôpital Saint-Antoine Paris France Recruiting
APHP - hôpital Pitié-Salpêtrière Paris France Recruiting
Hôpital Tenon Paris France Recruiting
Hôpital la Milétrie Poitiers France Not Yet Recruiting
Hôpital Pontchaillou Rennes France Not Yet Recruiting
Hôpital Charles-Nicolle Rouen France Recruiting
Nouvel hôpital civil Strasbourg France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06213168 on ClinicalTrials.gov ↗ ← All trials in France